DeviceClearance

K190651

Substantially Equivalent

ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter

Applicant
Erbe Elektromedizin GmbH
Product code
GEH
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tuebingen, DE
Download summary PDF View on FDA.gov ↗

Adverse events under product code GEH

product code GEH
Death
25
Injury
351
Malfunction
901
Total
1,277

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.